MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., BARREL BUR, 12 FLUTE F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 0375941012

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the tip of the device fell off during the procedure.The piece was retrieved.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future re-occurrence.Alleged failure: tip of device fell off.Probable root cause: inadequate window profile; inadequate welding process; improper material strength; inadequate size selected for the application; material brittleness; excessive force applied by the user; incorrect rfid tag.Manufacture date is not known.

Event Description

It was reported that the tip of the device fell off during the procedure.The piece was retrieved.

• Brand Name: PKG., BARREL BUR, 12 FLUTE F - SERIES - 4.0MM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10105165
• MDR Text Key: 193641258
• Report Number: 0002936485-2020-00218
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 37613327054751
• UDI-Public: 37613327054751
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375941012
• Device Lot Number: 19078CE2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1